Bioresearch Monitoring Alert articles from June 2004

Bioresearch Monitoring Alert archives from June 2004

N.Y. suit against GlaxoSmithKline seen spurring more litigation involving clinical trials.(Sponsors/monitors)
June 1, 2004... A lawsuit filed June 2 by crusading New York State Attorney General Eliot Spitzer against GlaxoSmithKline (GSK) regarding the prescribing of Paxil (paroxetine) for children could pave the way for other state attorneys general, and possibly...

OHRP, FDA still seeking more guidance, requirements on IRBs.(IRBs)(Office of Human Research Protections)(Food and Drug Administration)
June 1, 2004... Philadelphia -- While many talk about "overburdened IRBs," FDA and the Office of Human Research Protections (OHRP) are still engaged in providing more guidance and requirements on IRBs in terms of overseeing clinical trials. Addressing an...

Process continues to be flawed, subjects want to believe study drug is superior: experts.(Informed consent)
June 1, 2004... PHILADELPHIA -- Despite recent attention to consent form language and readability, the informed consent process is still problematic, according to experts who addressed OHRP's Quality Improvement for Research Subject Protection conference here....

'Professionalized' ethics boards, more outsourcing seen for academic medical centers.(IRBs)
June 1, 2004... PHILADELPHIA -- IRBs have become more "professionalized," but they continue to lack necessary resources, says Gary Chadwick, associate provost and associate professor of Medical Humanities at the University of Rochester in Rochester, NY. ...

Some drug firms eyeing accreditation programs, GSK ethicist says.(Accreditation)(GlaxoSmithKline)
June 1, 2004... PHILADELPHIA -- Pharmaceutical companies may soon adopt their own human subject accreditation programs for IRBs and research institutions. Speaking here May 6 about trends in bioethics and their implications for industry-sponsored research,...

Doctor hit with 17-item 483 for failures in consent, personnel supervision, and reporting; also cited for Part 11.(Clinical investigators)
June 1, 2004... John Cassidy, M.D., Tulsa, OK, Dallas District Numerous deficiencies in the supervision of personnel, failure to obtain patient consent, failure to report Serious Adverse Events (SAEs), and failure to list known potential risks in informed...

Inspection yields no 483 for Chervinsky.
June 1, 2004... Paul Chervinsky, M.D., North Dartmouth, MA, Boston District An inspection of clinical investigator Paul Chervinsky, M.D., resulted in no 483, although FDA investigator Paraluman Leonin of the Stoneham, MA, resident post noted in the EIR the...

IRB inspection nets 9-part 483 and warning letter for Irvine hospital.(IRBs)
June 1, 2004... Irvine Regional Hospital and Medical Center, Irvine, CA, Los Angeles District An initial IRB inspection resulted in a nine-part 483 and warning letter for Irvine Regional Hospital and Medical Center, Irvine, CA, including violations for...

Second inspection yields 3-item 483 for Geneva Labs.(CROs/contract testing labs)
June 1, 2004... Geneva Labs, Elkhorn, WI, Minneapolis District Minneapolis inspector Charles Cote, conducting a second inspection of Geneva Labs, Elkhorn, WI, issued a three-item 483 to this testing laboratory specializing in the testing of...

Warning letters.(Public Notice)
June 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of May 3, 10, 17, 24 and 31 and June 7, 2004. Each letter is $7 plus retrieval. Please order by...

IRB determination letters.(Internal Revenue Bulletin)
June 1, 2004... The following are Compliance Determination Letters for IRBs issued in March and April by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to...

BiMo FOIA log.(Freedom of Information Act)(Brief Article)
June 1, 2004... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...